![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000016612 |
Receipt No. | R000019280 |
Scientific Title | AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study |
Date of disclosure of the study information | 2015/02/23 |
Last modified on | 2019/03/27 |
Basic information | ||
Public title | AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study | |
Acronym | AFIRE Study | |
Scientific Title | AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study | |
Scientific Title:Acronym | AFIRE Study | |
Region |
|
Condition | ||
Condition | Non-valvular atrial fibrillation | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of rivaroxaban monotherapy compared to rivaroxaban in co-administration with a single anti-platelet therapy in non-valvular atrial fibrillation patients with stable coronary artery diseases.
For the efficasy of rivaroxaban monotherapy, for the composite endpoint incidence of cardiovascular events or all-cause mortality for the rivaroxaban and anti-platelet drugs single agent combination therapy to verify the non-inferiority. for safety, to verify the superiority for serious bleeding complications incidence. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | (1)Primary efficacy endpoints
Composite endpoint of cardiovascular events (stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularizations or all-cause mortality) (2)Safety primary endpoints Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) |
Key secondary outcomes | 1)Net adverse clinical and cerebral events (NACCE) (net clinical benefit)
All-cause death, myocardial infarction, stroke and major bleeding 2)Ischemic cardiovascular events and death (1)All-cause mortality (2)Cardiovascular death (3)Non-cardiovascular death (4)Myocardial infarction (5)Unstable angina pectoris requiring revascularization (6)Ischemic stroke (7)Transient ischemic attack (8)Systemic embolism (9)PCI/CABG (10)Stent thrombosis (11)Ischemic stroke and systemic embolism 3)Any bleeding 4)Adverse events excluding hemorrhagic events 5)Comparison of the primary endpoints between patients treated with aspirin and treated with thienopyridine derivatives 6)Stratified analysis of the primary endpoints, ischemic cardiovascular events and mortality according to the CHADS2 score and CHA2DS2-VASc score 7)Stratified analysis of the incidences of the primary endpoints, ischemic cardiovascular events and mortality according to subject characteristics 8)Stratified analysis of major bleeding and all bleeding events in patients treated concomitantly with any antiplatelet and patients not treated with any antiplatelet according to the HAS-BLED score and analysis of specificity and sensitivity 9)Comparison of the incidence of bleeding events according to whether or not proton pump inhibitors (PPIs) are used 10)Comparison of the incidences of the primary endpoints according to whether rivaroxaban is administered in the morning or evening 11)Investigation of relationships between ischemic cardiovascular events, bleeding events/adverse events and discontinuation of treatment with antithrombotic agents 12)Investigation of relationships between prothrombin time at trough and bleeding events and the cutoff values according to whether or not antiplatelet drugs are concomitantly used 13)The incidence of the primary endpoints according to adherence |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Rivaroxaban monotherapy
Rivaroxaban will be orally administered at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min until end of study. |
|
Interventions/Control_2 | Rivaroxaban co-administered with single anti-platelet therapy
Rivaroxaban and a single antiplatelet will be orally administered until end of study. Antiplatelet will be selected from aspirin or thienopyridine derivatives (clopidogrel or prasugrel). Rivaroxaban administration: Rivaroxaban will be orally administered after a meal at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min (regardless of time). Aspirin administration: Aspirin will be orally administered once a day at a dose of 81 mg or 100 mg. Clopidogrel administration: Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg. The dose will be reduced to 50mg once a day by consideration for aging, body weight or clinical findings. Prasugrel administration: Prasugrel will be orally administered once a day at a dose of 3.75 mg. If the body weight is 50kg or less than 50kg, the dose will be considered to reduce to 2.5 mg once a daily by evaluation for aging, renal function or other bleeding risk and thrombotic risk. |
|
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or more at the obtaining of informed consent, CHADS2 score are 1 or more, and fulfil the criteria below and can provide written consent for participation in the present study will be eligible.
1) Patients who underwent percutaneous coronary intervention, including plain old balloon angioplasty, at least one year ago 2) Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography 3) Patients who underwent coronary artery bypass graft CABG at least one year ago |
|||
Key exclusion criteria | 1)Patients who are contraindicated for rivaroxaban
2)Patients who are contraindicated for aspirin, thienopyridine derivatives (clopidogrel or prasugrel) 3)Patients who underwent PCI, including POBA, in the past one year 4)Patients who are going to undergo revascularization 5)Patients who have a past history of stent thrombosis 6)Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy) 7)Patients who have active tumors 8)Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission based on two or more measurements: 160 mmHg or more) 9)Patients who cannot discontinue treatment with antiplatelet drugs (the physician in charge will make a decision on the basis of the lesion shape, lesion site and type of stents.) (10)Patients judged as inappropriate for this study by investigators Contraindicated for rivaroxaban (1)Unstable CAD (2)Patients with a past history of stent thrombosis (3)Patients judged as inappropriate for this study by investigators |
|||
Target sample size | 2200 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Japan Cardiovascular Research Foundaition | ||||||
Division name | National Cerebral and Cardiovascular Center | ||||||
Zip code | |||||||
Address | 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan | ||||||
TEL | +81-6-6872-0010 | ||||||
afire@jcvrf.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Japan Cardiovascular Research Foundation | ||||||
Division name | Administration Office | ||||||
Zip code | |||||||
Address | 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan | ||||||
TEL | 06-6872-0010 | ||||||
Homepage URL | |||||||
afire@jcvrf.jp |
Sponsor | |
Institute | Japan Cardiovascular Research Foundation |
Institute | |
Department |
Funding Source | |
Organization | Bayer Yakuhin , Ltd |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 独立行政法人 国立循環器病研究センター(大阪府)
熊本大学医学部附属病院(熊本県) 大阪医科大学(大阪府) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019280 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |